Neoadjuvant Anti-PD-1 Antibody (Toripalimab) or Combined With Chemotherapy in HNSCC Patients

• Status: Unknown status
• Trial end date: 2021-11-07
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluate either Toripalimab or combined with chemotherapy as neoadjuvant treatment for patients with head and neck squamous cell carcinoma. Participants in arm A receive Toripalimab, in arm B receive Toripalimab plus PC (paclitaxel and carboplatin), arm C with Toripalimab plus modified TPF(paclitaxel and cisplatin and 5-fu).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital of Zhejiang University
• Treatments: Albumin-Bound Paclitaxel; Antibodies; Carboplatin; Cisplatin; Immunoglobulins; Paclitaxel

Criteria

Inclusion Criteria:

• Confirmed pathologic or cytologic diagnosis of squamous cell carcinoma of head and neck;

• Resectable or potentially resectable lesion;

• ECOG PS 0-1;

• Age >18 years old;

• At least one target lesion according to RECIST 1.1;

• Proper function of the cardiovascular system, liver, kidney and bone marrow for receiving chemotherapy and surgery;

Exclusion Criteria:

• Distant metastasis;

• Second malignancy within 5 years;

• Nasopharyngeal carcinoma;

• Active autoimmune diseases;

• HIV infected;

• Required prednisone dose >=10mg daily;

• Heart attack within 6 months;

• Stroke within 6 months;

• Other conditions that investigators consider the patients are not suitable for PD-1antibody;